Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months (NiCOL)

Sponsor
Institut Curie
Study ID
NCT03298893
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab Injection — DRUG
    2 possible doses : flat dose 240 mg q2 weeks or 1mg/kg q2 weeks
  • Cisplatin — DRUG
    40 mg/m2, once a week during radiotherapy
  • radiotherapy — RADIATION
    Intensity-modulated radiation therapy (including volumetric-modulated arc therapy and tomography) will be used. A dose of 45 Gy will be delivered to the pelvis in 25 fractions of 1.8 Gy using a 6-MV photon energy. An additional dose of 54 Gy in 25 fractions of 2.16 Gy may be delivered to invaded lymph nodes using SIB-IMRT. An additional lateral pelvic dose may be delivered if coverage of the target volumes is judged insufficient. The volumes, doses and techniques will be those usually used in each center.

Study Details

To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as monotherapy, and the next logical step is to evaluate rational therapeutic associations. The aim of the NiCOL study is to assess the safety of nivolumab in association with chemoradiation therapy and to gain initial insight into its efficacy in association with the current standard of care, including chemoradiation.

Key Dates

Start date
Nov 27, 2017
Status verified
Sep 2025
Primary completion
Oct 30, 2020
Completion
Mar 7, 2022

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + radiochemotherapy
    5 weeks of radiochemotherapy + nivolumab followed by 5 months of nivolumab alone

Primary Outcome Measure

rate of occurrence of dose-limiting toxicity (DLT) [ Time Frame: within 11 weeks after the initiation of treatment. ]

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